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Alexion Pharmaceuticals obtains orphan drug designation from EC for Soliris

Alexion Pharmaceuticals obtains orphan drug designation from EC for Soliris

Alexion Pharmaceuticals, Inc. today announced that the European Commission has granted an orphan drug designation (ODD) to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of graft rejection following solid organ transplantation. Graft rejection can cause severe injury to the transplanted organ and is a significant barrier to successful transplantation. [More]
Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Johnson & Johnson today announced sales of $18.1 billion for the first quarter of 2014, an increase of 3.5% as compared to the first quarter of 2013. Operational results increased 5.3% and the negative impact of currency was 1.8%. Domestic sales increased 2.2%. International sales increased 4.5%, reflecting operational growth of 7.9% and a negative currency impact of 3.4%. [More]
Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. [More]
Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). [More]
Perioperative aspirin increases risk of serious bleeding after non-heart-related surgery

Perioperative aspirin increases risk of serious bleeding after non-heart-related surgery

​Patients given aspirin to prevent heart problems after non-heart-related surgery had a higher risk of serious bleeding than the patients who did not receive aspirin. [More]

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy. [More]

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

Daiichi Sankyo Company, Limited today announced that it has started enrolling patients into the ENSURE-AF multinational phase 3 study, which will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm). [More]

Poor blood pressure control increases stroke risk in patients with atrial fibrillation

Poor blood pressure control among patients with atrial fibrillation is associated with a 50-percent increased risk of stroke, according to an analysis presented by Duke Medicine researchers. [More]

Genetic testing could help determine drug dosage, reduce side effects

Usually pharmaceutical companies determine the drug dosage just as a mean value. This amount may be too much for patients who absorb the substance faster, and too little for those with a slower metabolism. [More]

ATS develops clinical practice guidelines to help clinicians identify, manage patients with sickle cell disease

The American Thoracic Society has developed clinical practice guidelines to help clinicians identify and manage patients with sickle cell disease who are at increased risk for mortality from pulmonary hypertension. [More]

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. [More]
Statins combined with conventional blood clot prevention therapies, reduce VTE risk by 48%

Statins combined with conventional blood clot prevention therapies, reduce VTE risk by 48%

Statins have long been known to lower cholesterol and, more recently, to decrease the risk of deep vein thrombosis (blood clots) in healthy, non-surgical patients. [More]

Regado receives Fast Track designation from FDA for REG1

Regado Biosciences, Inc., a biopharmaceutical company focused on the development of actively controllable therapeutics, today announced that the United States Food and Drug Administration has designated REG1 for anticoagulant therapy to be used in patients with coronary artery disease during percutaneous coronary interventions (PCI) as a Fast Track development program. [More]

New optical device may help docs to diagnose blood coagulation status in near real time

​Defective blood coagulation is one of the leading causes of preventable death in patients who have suffered trauma or undergone surgery. The body's natural defense against severe blood loss is the clotting process, in which platelets, plasma proteins, and other blood components interact to form a sticky, mesh-like structure. [More]
AAN guideline suggests people with irregular heartbeat to take oral anticoagulants to prevent stroke

AAN guideline suggests people with irregular heartbeat to take oral anticoagulants to prevent stroke

An updated guideline from the American Academy of Neurology recommends that people with nonvalvular atrial fibrillation, or irregular heartbeat, take oral anticoagulants, a type of blood thinner pill, to prevent stroke. [More]
Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013. [More]
Researchers use cardiac monitor to assess atrial fibrillation after cryptogenic stroke

Researchers use cardiac monitor to assess atrial fibrillation after cryptogenic stroke

Larry Ambrose woke up one night, wandered into his kitchen but couldn't completely read the time on his microwave. A few days later when he noticed his blood pressure was unusually high, he went to the hospital and was diagnosed as having a stroke. [More]

Study shows one-quarter of high risk patients do not receive anticoagulants after ablation of AF

​One-quarter of high risk patients do not receive anticoagulants after ablation of atrial fibrillation (AF), according to the latest survey of European practice. [More]

Study reveals overall success rate of AF ablation in Europe

One-quarter of high risk patients do not receive anticoagulants after ablation of atrial fibrillation (AF), according to the latest survey of European practice. [More]

FDA accepts Regado Biosciences' IND application for REG2

Regado Biosciences, Inc., a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced that the United States Food and Drug Administration has accepted the company's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future. [More]